Apparatus and method for isolated pelvic perfusion

ABSTRACT

The instant invention provides a novel apparatus, kit and process for isolating a flow circuit within the pelvic cavity of a patient for perfusing a high concentration of a chemotherapeutic agent therethrough, without contaminating the blood circulating in the substantial remainder of the patient&#39;s blood circulatory system with the agent.

BACKGROUND OF THE INVENTION

The instant invention relates to the treatment of tumors in the body ofa patient inflicted with cancer. More specifically, the inventionrelates to the chemotherapy treatment of tumors in the body of a patientinflicted with cancer. Still more specifically the invention relates tothe treatment by chemotherapy of tumors in the pelvic cavity of the bodyof a patient inflicted with cancer

Chemotherapy is the treatment of disease using chemical agents that areintended to eliminate the causative organism without harming thepatient. In the strict sense, this applies to the use of antibiotics totreat such invading organisms as bacteria, viruses, fungi, or parasites.The term is commonly used, however, to describe the use of drugs totreat cancer, in which case the target is not a causative organism butwildly multiplying cells. The purpose of the therapy is to selectivelykill tumor cells and leave normal cells unharmed--a very difficult taskbecause drugs have a narrow therapeutic zone beyond which they harmnormal cells as well as cancer cells. Approximately 50 differentanticancer drugs are available, and an equal number are currently beingtested. Anticancer drugs are only relatively selective for cancer cells,and the toughest task for the physician is to select a drug that willdestroy the most cancer cells, leave normal cells unharmed, and causethe fewest unpleasant and undesirable side effects. The therapeutic goalis to favorably balance the risk-benefit ratio in which the morbidity ofthe treatment is weighed against its potential benefits. If a treatmentcauses patients to be miserable and has only a slight chance ofprolonging life, many patients will forego further treatment. However,if the potential for significantly prolonging survival by aggressivetherapy exists, the patient may decide to continue with the therapy.

Prior to the instant invention, chemotherapy has not been a particularlyeffective mode of treating tumors occurring in the pelvic cavity.

Thus it is the primary object of the instant invention to provide anovel apparatus and process for the localized perfusion of a highconcentration of an anti-cancer agent through a tumor occurring thepelvic cavity of a patient, without substantially contaminating theblood circulating in the substantial remainder of the patient's bloodcirculatory system with the agent. The invention enables the by-pass ofthe contaminated blood through an extracorporeal circuit which includesa scheme for decontaminating the contaminated blood. Afterdecontamination, the blood is thereafter infused back into the body ofthe patient at a point remote from where it was initially withdrawn.Thus, the invention prevents otherwise toxic levels of such agents fromentering the substantial remainder of the patient's blood circulatorysystem; while at the same time, delivering doses of the agent which aresubstantially lethal only to the tumor. The improvement to the apparatusdisclosed herein is applicable to a great variety of prior art apparatushitherto used for conducting processes similar to that instantlydisclosed.

U.S. Pat. No. 5,597,377, to Aldea teaches a catheter for retroperfusionof myocardium has an infusion tip, such that when retroperfusingmyocardium, the tip extends within the coronary sinus to a depth in arange of about 2 to 4 inches (5 to 10 cm) from the coronary sinusostium. The catheter also comprises a tube defining at least threechannels. The channels include an infusion channel, which has a firstinfusion end coupled to an infusion port located in the infusion tip anda second infusion end coupled to an outlet orifice of a pump; awithdrawal channel, which has a first withdrawal end coupled to awithdrawal port located in the superior vena cava and a secondwithdrawal end coupled to an inlet orifice of the pump; and a pressuremonitoring channel for monitoring pressure at pressure port at theinfusion tip having a first monitoring end coupled to the pressure portand a second monitoring end coupled to a pressure sensor. The catheteralso has a microprocessor for controlling the pump and measuring a rateof retroperfusate flow, whereby autologous venous blood entering thewithdrawal port is continuously discharged at the infusion port at aflow rate in a range of about 5 to 50 mil./min. and at a pressure lessthan about 15 mm Hg. The tube and tip are made from biocompatible,non-thrombogenic material. Further, the catheter has remotelyidentifiable markers spaced along the tube, and a marker is located atsaid infusion tip. The invention also is a method for coronary sinusretroperfusion. The method includes the steps of inserting the catheterthrough the patient's jugular vein; guiding the catheter's infusion tipinto the coronary sinus, such that when retroperfusing myocardium, thetip extends within the coronary sinus to a depth in a range of about 2to 4 inches (5 to 10 cm) from the coronary sinus ostium; and providing anon-synchronized retroperfusate flow of autologous venous blood at arate in a range of about 5 to 50 mil./min. and at a pressure less thanabout 15 mm Hg.

U.S. Pat. No. 5,569,182 Twardowski, et. al., teaches blood which iscirculated through a multiple lumen catheter which connects between avein of a patient and the blood treatment device. The catheter and thelumens thereof each define distal ends which are positioned within thevein. By this invention, one withdraws blood from the vein through oneof the lumens at a flow rate of at least about 200 ml./min. while alsoinserting blood into the vein through another of said lumens at asimilar flow rate. The distal ends of the lumens are longitudinallyspaced from each other by no more than about 5 mm. It have been foundthat the following advantages can be achieved by this method: less clotformation coupled with low direct blood recirculation and longercatheter survival. Also, the catheter works well in either direction ofblood flow through the respective lumens.

U.S. Pat. No. 5,509,897, to Twardowski, et. al., teaches a catheter forhemodialysis comprises a flexible catheter tube defining a plurality ofseparate lumens. The catheter defines an arc angle of generally U-shapein its natural, unstressed configuration. Thus, the catheter may beimplanted with a distal catheter portion residing in a vein of thepatient, the distal catheter portion being of substantially the shape ofthe vein in its natural, unstressed condition. Also, a proximal catheterportion resides in a surgically created tunnel extending from the veinand through the skin of the patient, this section of the Catheter alsobeing typically in its natural, unstressed condition. Thus blood may beremoved from the vein through one lumen of the catheter, and blood maybe returned to the vein through another lumen of the catheter, while thecatheter is subject to long term indwelling in the body. Improvedresults are achieved because of the lack of mechanical stress in theshape of the catheter, which stress causes the catheter to press undulyagainst adjacent tissues.

U.S. Pat. No. 5,505,698, to Booth, et. al., teaches a catheter forsupplying liquid to the coronary sinus in a perfusion procedurecomprising a tubular catheter body having an interior lumen, a proximalend, and a distal end; and an inflatable cuff (balloon) adjacent thedistal end of the catheter. The cuff has a proximal end and a distalend, each of which encircle the catheter body and hermetically sealthereto. The cuff further comprises an elongated central section havinga length of at least 1 inch. When the inflated cuff is positioned asufficient distance into the coronary sinus to firmly retain the cufftherein, it blocks the left coronary vein where it meets the coronarysinus. Further, the cuff can comprise end panels defined between thecentral section and the proximal and distal cuff ends. The end panelshave a shape which allows for flexure between the central section andthe cuffs proximal and distal ends.

U.S. Pat. No. 5,489,274, to Chu, et. al., teaches an easy operating,durable closure device for controlling the closure of a passageway infor example valves and the like used in medical applications. The deviceincludes a cam surface arranged about the circumference of a resilienttubing member. Rotation of the cam controls the radial position of acompression member that compresses the tubing member to effect closure.Such a closure device, or a two-part rotary closure device in general,is constructed to receive an accessory component such as a syringe, therotary connecting movement of which automatically opens the closuredevice. The device may be used as a torqugeable handle for a guidewiregripped in the passage. A large scale version of the device is joined toan introducer sheath, sized to pass an introducer catheter for e.g., aGreen field filter, or to close upon a guidewire to prevent backflow ofblood.

U.S. Pat. No. 5,462,529, to Simpson, et. al., teaches a catheter devicefor treatment of disease in biological conduits. The device has innerand outer coaxial catheter members, each having an inflatable balloonattached near its distal end. When the balloons are inflated, a sealedtreatment chamber is created between the balloons. The length of thetreatment chamber is adjustable by sliding the coaxial catheter memberswith respect to each other to obtain a desired separation between theattached balloons before inflation. Biological debris is trapped withinthe chamber and removed by infusion and aspiration of a flushing fluid,reducing the risk of myocardial infarction. Adjunctive treatment devicescan be inserted into the sealed treatment chamber through a lumen of theouter coaxial member.

U.S. Pat. No. 5,458,583, to McNeely, et. al. A system and method forinserting a gastrostomy catheter through a passageway formed through theabdominal and stomach walls of a patient. The gastrostomy catheter ismounted onto a dilatation catheter with a dilatation member such as aninelastic balloon on the distal extremity thereof. An introducer needleis first advanced through the walls of the patient's abdomen and stomachinto the interior of the stomach and then a guidewire is advancedthrough the inner lumen of the needle into the stomach interior. Thegastrostomy catheter-dilatation catheter assembly is advanced over theguidewire until the balloon on the dilatation catheter is in properposition crossing both the abdominal and gastric walls. Upon inflationof the balloon on the dilatation catheter, the passageway is expandedenough so that the gastrostomy catheter can be advanced therethrough todispose the distal end of the gastrostomy catheter within the interiorof the stomach. The balloon on the distal end of the gastrostomycatheter is inflated so as to form an internal retention member and thecatheter withdrawn in order to urge the inflated balloon against thestomach wall. Preferably, the gastrostomy catheter has an externalretention ring on the shaft thereof which is slid against the exteriorof the patient's abdomen to seal the passageway through the abdominalwall.

U.S. Pat. No. 5,423,745 to Todd, et. al., teaches balloon catheters foruse in infusing a solution into a body passageway, and their methods ofuse and manufacture. Each catheter contains at least one lumen throughwhich a solution flows into the body. The balloons of each catheter aresecured to the proximal end of the catheter, and each have a pluralityof protuberances projecting outwardly from the outer surface of theballoons for the purpose of firmly gripping the walls of the bodypassageway so as to secure placement of the catheter within thepassageway. A malleable wire assists in retaining the catheter inposition within the body passageway. A double balloon catheter allowssealing of the body passageway to be accomplished separately fromsecurely gripping the walls.

U.S. Pat. No. 5,405,320, to Twardowski, et. al., teaches a catheter forhemodialysis comprises a flexible catheter tube defining a plurality ofseparate lumens. The catheter defines an arc angle of generally U-shapein its natural, unstressed configuration. Thus, the catheter may beimplanted with a distal catheter portion residing in a vein of thepatient, the distal catheter portion being of substantially the shape ofthe vein in its natural, unstressed condition. Also, a proximal catheterportion resides in a surgically created tunnel extending from the veinand through the skin of the patient, this section of the catheter alsobeing typically in its natural, unstressed condition. Thus blood may beremoved from the vein through one lumen of the catheter, and blood maybe returned to the vein through another lumen of the catheter, while thecatheter is subject to long term indwelling in the body. Improvedresults are achieved because of the lack of mechanical stress in theshape of the catheter, which stress causes the catheter to press undulyagainst adjacent tissues.

U.S. Pat. No. 5,398,687, to Abell, teaches new devices and methods fordetecting and diagnosing motility abnormalities within thepancreaticobiliary tree. In the first device, a modified ERCP catheterwith electrical activity sensing is positionable within the biliarytract, and operates to sense electrical activity during the ERCPprocedure. Electrical activity is sensed by two circumferential leadsformed by bands of silver, located near the distal tip of the catheter.The detection of electrical activity, in combination with thesimultaneous radioscopic visualization of the biliary tract, provides adetailed motility profile for the physician without requiring theadditional use of a perfusion catheter. A second device is alsodisclosed which detects motility within the biliary tract by thesimultaneous sensing of electrical activity and surrounding fluidpressure. A biliary catheter has two circumferential silver leads andthree perfusion lumens whose outlets are alternately spaced between thesilver leads. When positioned within the biliary tract, this catheteryields valuable data correlating electrical activity and thecorresponding occurrence of muscle activity. By the sequential detectionof pressure changes at the proximal, medial, and distal perfusionoutlets interspersed between the electrical activity leads, both thepresence and direction of muscle activity are sensed in relation to thesensed electrical activity about the leads.

U.S. Pat. No. 5,397,310, to Chu, et. al., a catheter introducer sheathassembly, for introduction into a body passage of a catheter containinga filter comprises a flexible introducer sheath joined to the distal endof a closure device forming a through-passage with a diameter sufficientto pass the catheter therethrough. The closure device has a resilientmember in the through-passage and two rotatable body portions, onestationary with respect to the resilient member, and the other rotatableabout the axis of the resilient member with an internal camcircumferentially spaced around the axis. A compression memberpositioned radially in an extending aperture makes contact with both theresilient member and the cam surface to vary the through-passageallowing the operator to manually control the passage of the device. Thesheath assembly receives a cathetory guidewire that slides through andextends beyond the closure device and the sheath. In another aspect, thecombination sheath assembly and closure device forms a catheterintroducer kit constructed to receive a stabilizer and a catheter ofsufficiently large diameter to house a vena cava filter, and to pass thefilter through the closure device and sheath for placement in the bodyby means of a dilator attached to the end of the sheath to facilitateguiding the filter to the desired position for its release from thesheath. The closure device is adjustable to prevent any backflow offluid such as blood from the assembly during the filter placementprocedure.

U.S. Pat. No. 5,397,307, to Goodin, teaches an intravascular materialdelivery dilation catheter having a pair of longitudinally spacedinflatable balloons with a drug delivery region defined therebetween.The catheter is ideally suited for use after a PTCA procedure, whereinthe proximate balloon seals the blood vessel while the distal balloon isuniquely contoured when inflated to define fluid communication pathstherepast and proximate a blood vessel to be treated. The distalballoon, when inflated, has four lobes but could also be textured. Eachlobe is separated from the next by a groove, which groove in combinationwith the blood vessel inner wall forms a fluid communication paththerebetween. Upon inflation of both balloons in a blood vessel, amedicament such as heparin can be injected, via the drug delivery regionbetween the inflated balloons, wherein the medicament flows past thedistal balloon at a selected rate. Accordingly, a medicament can beinjected directly to a treatment site rather than injected as a bolusdose, thus, a smaller dosage may be employed to minimize side effects.Alternatively, perfusion can be accomplished by only partially inflatingthe proximate balloon to constrict flow therepast, or eliminating theproximate balloon entirely, where the drug delivery region is disposedupstream of the contoured distal balloon.

U.S. Pat. No. 5,370,614, to Amundson, et. al., teaches a ballooncatheter includes a sheath surrounding the balloon, the sheath having alongitudinal line of weakness and a drug-containing viscous matrixmaterial intermediate between the balloon and the sheath such that whenthe balloon is positioned and inflated in the body lumen it causes thesheath to burst at the line of weakness and release viscous matrixmaterial onto said body lumen. The device provides accurate placement ofthe dosage required at the location in need of treatment. The catheteris especially useful in balloon angioplasty procedures.

U.S. Pat. No. 5,338,301, to Diaz, teaches an extendableballoon-on-a-wire catheter which includes a telescoping exchange corewire mounted along the inside lumen of the longitudinal tube of theballoon-on-a-wire assembly. In the preferred embodiment, the exchangecore wire is mounted within a hypodermic tube secured to the core wireof the balloon-on-a-wire assembly. A multiple component system includesthis balloon-on-a-wire assembly together with an over-the-wire catheterwhich slidably passes over the elongated body of the balloon-on-a-wireassembly. Preferably, the relative sizing of these components of thesystem is such that the over-the-wire catheter does not pass over theballoon of the balloon-on-a-wire assembly. In a treatment procedure, theballoon-on-a-wire assembly achieves dilation of a lesion or a stenosis,after which it is moved somewhat distally to clear the stenosis. Whenthe over-the-wire catheter is used, it is slidably moved over theballoon-on-a-wire assembly until its treatment location reaches thestenosis. During the procedure, the exchange core wire can betelescopically extended to a length such that the surgeon can readilygrasp the balloon-on-a-wire assembly or its exchange core wire duringmanipulation of the over-the-wire catheter.

U.S. Pat. No. 5,324,261, to Amundson, et. al., teaches a ballooncatheter includes a sheath surrounding the balloon, the sheath having alongitudinal line of weakness and a drug-containing viscous matrixmaterial intermediate between the balloon and the sheath such that whenthe balloon is positioned and inflated in the body lumen it causes thesheath to burst at the line of weakness and release viscous matrixmaterial onto said body lumen. The device provides accurate placement ofthe dosage required at the location in need of treatment. The catheteris especially useful in balloon angioplasty procedures.

U.S. Pat. No. 5,304,121, to Sahatjian, teaches a catheter and methodsfor delivering drug to tissue at a desired location of the wall of abody lumen. The catheter is constructed for insertion in a body lumenand has a catheter shaft and an expandable portion mounted on thecatheter shaft. The expandable portion is expandable to a controlledpressure to fill the cross-section of the body lumen and press againstthe wall of the body lumen. In one embodiment, at least a portion of theexterior surface of the expandable portion is defined by a coating of atenaciously adhered swellable hydrogel polymer. Incorporated in thehydrogel polymer is an aqueous solution of a preselected drug to bedelivered to the tissue or plaque. The hydrogel polymer and drug areselected to allow rapid release of a desired dosage of the drug from thehydrogel polymer coating during compression of the hydrogel polymercoating against the wall of the lumen when the expandable portion isexpanded. In other embodiments the polymer is released from theexpandable portion in response to pressure, to coat the wall of the bodylumen.

U.S. Pat. No. 5,286,259, to Ganguly, et. al., teaches a catheter (10)having a stepped coaxial construction formed by and internal tube 12)and an external tube (14). The internal tube includes a distal pressurelumen (26), a balloon inflation lumen (28), and a sensor lumen (30). Theexternal tube includes the first proximal pressure lumen (48), secondproximal pressure lumen (50), injection lumen (52), and transducer leadlumen (54). A cylindrical transducer (16), sensor (18), and balloon (42)are supported on the internal and external tubes, which allow thetransducer to be coaxially mounted thereon. The catheter has a highlumen count, large lumen cross-sectional area, is easy to construct anduse, and allows cardiac output to be measured continuously withoutsacrificing other currently available catheter functions.

U.S. Pat. No. 5,281,200, to Corso, Jr., et. al., teaches a ballooncatheter system which includes a balloon-on-a-wire assembly and anover-the-wire catheter which slidably passes over the elongated body ofthe balloon-on-a-wire assembly, but not over its balloon. In theprocedure by which the system is used, the balloon-on-a-wire assemblyachieves an initial dilation or predilation of a lesion or stenosis,after which it is moved somewhat distally to clear the predilatedstenosis. The over-the-wire catheter then is slidably moved over theballoon-on-a-wire assembly until its balloon reaches and dilates thepredilated stenosis. After dilation is completed, the system is removedfrom the body vessel thus treated.

U.S. Pat. No. 5,279,546, to Mische, et. al., teaches an apparatus andmethod for dissolving and removing material which tends to occlude abodypassage way, such as an artery. The device employs a dual cathetersystem arranged in coaxial fashion. Each of the catheters has aninflatable balloon at its distal tip. Inflating the two balloonsoccludes the body passage way both proximal and distal to the treatmentarea, thus isolating it from fluid contact with the rest of the body.Because concentric catheters are used, the distance between the balloonsand hence the size of the treatment area is adjustable. The thrombolyticagent is infused through orifices in the inner catheter in the regionbetween the two balloons. A piezo electric device supplies ultrasonicagitation within the treatment area. A pressure device monitors the bodypassage way for unsafe conditions. Aspiration is accomplished throughone or more lumens in the outer catheter. Ultrasonic agitation may beemployed with the aspiration also to break up masses of material whichmay be too big to pass through the exit lumen cross section.

U.S. Pat. No. 5,254,089, to Wang, teaches an inflatable medical devicefor the delivery of medications to an organ in the body includingacatheter having a plurality of lumens disposed therein. The distal endof the catheter is adapted to be disposed within a bodily organ. Ahollow, inflatable, medication-deliverable balloon is disposed on thedistal end of the catheter and the interior of the balloon is in fluidflow relationship with one of the lumens to enable the balloon to beinflated. An array of conduits is disposed within the walls of theballoon for the delivery of medications to predetermined locationswithin said bodily organ. Another lumen in the catheter shaft isprovided to deliver medications to the conduits in the wall of theballoon and an egress for the medications so that they may be dispensedat the site being treated.

U.S. Pat. No. 5,236,417, to Wallis, teaches a cholangiography catheterfor injecting dye into a cystic duct during laparoscopiccholangiography. The catheter includes a bifurcated connector having alength of tubing and a check valve mounted to each arm of the connector.A saline syringe is coupled to one check valve and a dye syringe iscoupled to the other check valve. The check valves and respectivesyringes are color coordinated to preclude inadvertently using the wrongsyringe. The catheter is fabricated from a medical grade polymer havinga preselected degree of compliant memory and includes indicia forproviding a visual indication of the depth of penetration of the tip ofthe catheter into the cystic duct.

U.S. Pat. No. 5,226,427, to Buckberg, et. al., teaches a stylet for usewith a retrograde cardioplegia catheter and its methods of use. Thestylet includes a stylet rod, a handle on the proximal end of the styletrod and apredetermined curve in the distal end of the stylet rod. Thehandle has a thumb rest on the proximal end and a one or two fingerloops extending outward from the handle. An obturator is located on thedistal end of the predetermined curve to impede blood flow through a tipof the cardioplegia catheter during insertion of the catheter. Theinvention also contemplates methods for using the stylet.

U.S. Pat. No. 5,209,723, to Twardowski et. al., teaches a multiplelumen, intravenous catheter for hemodialysis or the like defines adistal end portion in which at least a pair of the catheter lumens eachcommunicates with the exterior through aperturemeans. By this inventionthe aperture means of one of the lumens defines a first port atessentiallythe distal catheter end, and the aperture means of the otherof the lumens defines a second port spaced proximally along the catheterfrom the distal end and first port. The second port is positioned toface radially inwardly to at least a slight degree to avoid engagementof the wall of the blood vessel that the catheter occupies.Additionally, the tip of the catheter distal of the second port ispreferably of substantially helically shape, being sized to assist inkeeping the second port away from the blood vessel wall. As anotherfeature, the catheter may be angled in its as-manufactured, unstressedcondition to avoid pressing by elastic memory against internal bloodvessel walls. Also, the catheter may define an inflatable balloonpositioned between the first and second ports as a means for spacingparticularly the second port away from blood vessel walls.

U.S. Pat. No. 5,209,717, to Schmoll, et. al., teaches a method and adevice for the application and the removal of locally applied activesubstances against solid tumors, which device consists of a catheter (1)to be positioned distally to the tumor for the collection of bloodcoming from the tumor, a pump (2) and a catheter (3) connected theretoand returning the blood into the body. The device is characterized inthat between the two catheters (1, 3) there is present at least onecontainer (4) capable of allowing blood to pass therethrough andcontaining immobilized substances having high affinity against theapplied active substance.

U.S. Pat. No. 5,209,239, to Watanabe, et. al., teaches an apparatus forcystographic inspection used for observing and measuring theurethrophaxis portion and posterourethovesical angle of a patient of theacraturesis caused by a ventral pressure. The apparatus comprises acatheter, in the housing of which a flexible urethral locus indicatingmember, provided with a marking member, is positioned. The flexedcondition of the urethral and the posterourethrovesical angle can beclearly confirmed by the urethral locus indicating member, and theposition of an exterior urethral opening member, and position of anexterior urethral opening can be surely grasped by the marking memberwhich can be roentgenographed and which is positioned on the urethrallocus indicating member and that it is prevented from penetrating intothe uretra and this assists in examining of the external urethralopening during roentgenography of the urethral locus indicating memberof the catheter.

U.S. Pat. No. 5,167,623, to Cianci, et. al., teaches a multilumencatheter having a distal portion with a soft tip and reducedcross-section. The multilumen catheter of the present invention includesa flexible, elongated first catheter tube and a flexible, elongated,dual-lumen catheter tube which has a first and second lumens integrallyformed and is disposed within the first catheter tube. The cross-sectionof the dual-lumen catheter tube is smaller than that of the firstcatheter tube and therefore, an independent, single lumen is defined inthe space between the first catheter tube and the dual-lumen cathetertube. The dual-lumen catheter tube extends beyond the distal end of thefirst catheter tube thereby providing an overall reduced cross-sectionof the distal portion of the present multilumen catheter. Furthermore,the dual-lumen catheter tube may be formed from a softer material thanthat of the first cathether tube thereby providing a softer distalportion of the present multilumen catheter. A protective hubencapsulates and secures the proximal ends of the first and dual-lumencatheter tubes, and facilitates fluid communication between each of thelumens and fluid transfer devices.

U.S. Pat. No. 5,167,622, to Muto, a suction catheter provided with threeconduits to provide th functions of suctioning, lavaging andoxygenating. The suction conduit is connected to a suction controlmember. The second conduit for the irrigating fluid is connected to asource of said fluid. The third conduit is connected to a source of gasunder pressure. The gas conduit terminates within the irrigation conduitto form a common chamber at the distal end of the irrigation conduitfrom which fluid is propelled out by the pressurized gas. The gas maypreferably contain oxygen.

U.S. Pat. No. 5,158,540, to Wijay, et. al., teaches a low-profileangioplasty catheter which is insertable through a guiding catheter. Theangioplasty catheter has two balloons. The distal balloon dilates thestenosis. The proximal balloon is separately inflatable and selectivelycloses the annular passage between the angioplasty catheter and theguiding catheter. The angioplasty catheter has a central lumen with aseries of openings allowing fluid communication from the central lumeninto the annular passage proximally of the balloon which seals theannular passage. While the first balloon is inflated to dilate thestenosis, blood can be withdrawn from an arterial source through a lumen(or plurality thereof) in the guiding catheter and pumped into theannular passage between the angioplasty catheter and the guidingcatheter. The blood then passes through the openings proximal to theproximal balloon into the central lumen of the PTCA catheter and flowsbeyond the distal tip of the angioplasty catheter to maintaincirculation of the patient's blood at a point distal of the stenosis.

U.S. Pat. No. 5,122,115, to Marks, teaches a multiple lumen catheterspecifically adapted for selective visualization of one or the other ofthe coronary arteries. One lumen of the multiple lumen catheter isadapted to deliver contrast agent to the coronary artery to bevisualized while a second, and optionally a third, lumen is adapted tolimit flow of contrast agent to one or more other locations in theaortic root complex. The invention also includes a method of preparingfor coronary angiography using such a catheter.

U.S. Pat. No. 5,120,323, to Shockey, et. al., teaches a guide cathetersystem for use in the treatment of coronary artery disease includes afirst single-lumen catheter of a relatively large internal diameter topass a second guide catheter therethrough. The first guide cathetercomprises an elongated flexible tube having a stainless steel braidembedded in the wall thereof for imparting desired torqueabilitycharacteristics to it. The first guide catheter is intended to beinserted at an appropriate point in the vascular system and thenadvanced until its distal end reaches the coronary ostium. The secondguide catheter is fabricated by extruding a plastic, such aspolyurethane thermoplastic resin over a tubular Teflon® core and becauseit is to be used within the lumen of the first catheter, it need notinclude a braided structure within its walls to prevent it from kinking.This allows the second catheter to be sufficiently slim to permit it tobe advanced into a coronary artery while allowing fluids to be perfusedbetween the outer wall of the second guide and the inner wall of thefirst guide catheter while still providing a sufficiently large innerlumen to pass a working catheter, e.g., an angioplasty or atherectomycatheter. An atraumatic tip is attached to the distal end of the secondguide catheter.

U.S. Pat. No. 5,106,363, to Nobuyoshi, a dilation catheter defining alumen and including a dilating member at the leading end, and a sheathdefining a bore through which the dilation catheter is inserted todefine a blood intake gap between the outer surface of the dilationcatheter and the sheath bore and including a transverse bore branchedfrom the sheath bore, a tube is connected at one end to the transversebore and at another end to the lumen of the dilation catheter at atrailing end. When the sheath having the dilation catheter insertedtherein is set in a blood vessel, a pump in the tube operates to takeblood into the blood intake gap in the sheath, pass through the tube andthe dilation catheter lumen, and feed back to the periphery of a lesionthrough the open leading end of the dilation catheter. The patient's ownfresh blood can be injected without the need for a further cutdown orpuncture for blood intake.

U.S. Pat. No. 5,102,390, to Crittenden, et. al., teaches a balloonangioplasty system includes a balloon dilatation catheter having aninflation and deflation lumen for the balloon and a main lumen extendingthe full length of the catheter to provide fluid communication from theproximal to the distal end of the catheter. A microdilatation probe hasa small diameter and can be passed through the main lumen of thedilatation catheter. The microdilatation probe has a balloon at itsdistal end which is collapsible to enable it to be passed through themain lumen of the dilatation catheter so that it can be projecteddistally beyond the distal tip of the dilatation catheter. The probeballoon is inflatable to a diameter no smaller than the diameter of theuninflated dilatation catheter. The probe and dilatation catheter areconstructed so that fluid communication is maintained through the mainlumen of the dilatation catheter while the microdilatation probe extendsthrough the catheter thereby enabling liquids to be infused and pressuremeasurements to be taken while the probe is in place. The probe mayinclude a distal tip which can hold a preset curve. In use, a stenosiswhich cannot be crossed by the dilatation catheter may be enlargedsufficiently to permit passage of the dilatation catheter by firstprojecting the dilatation probe into the stenosis, then inflating theprobe balloon to enlarge the lumen of the stenosis sufficiently tothereafter receive the dilatation catheter.

U.S. Pat. No. 5,084,031, to Todd, et. al., teaches a three-way doublestopcock and associated tubing with which to connect both a cardioplegiasolution source and a pressure monitor for the solution selectively andalternatively to either an antegrade cardioplegia catheter or aretrograde cardioplegia catheter. The stopcock includes a hollow valvebody with three solution infusion ports communicating to the interiorthereof in a coplanar arrangement at a first longitudinal point on thevalve body. Three cardioplegia pressure monitoring ports alsocommunicate through the valve body to the interior thereof at a secondlongitudinal position distinct from the first. Mounted in the valve bodyis a cylindrical valve core selectively rotatable about the longitudinalaxis thereof between a first position in which the cardioplegia solutionsource and the pressure monitor are coupled to the antegrade cannula anda second position in which the cardioplegia solution source and thepressure monitor are coupled to the retrograde catheter. Formed in thevalve core are a set of valving passageways for communicating withselective of the infusion ports and a set of valving passageways forcommunicating with selective of the pressure monitoring ports.

U.S. Pat. No. 5,021,045, to Buckberg, et. al., teaches a retrogradecardioplegia catheter and its method of use. The catheter contains twolumens, an infusion lumen through which the cardioplegic solution flowsand a pressure sensing lumen for monitoring the fluid pressure at thepoint where the solution exits the catheter. A slightly tapered,self-filling balloon is secured to the distal end of the catheter. Also,located at the distal end of the catheter is a soft, rounded tip toprevent damage to the sensitive intimal tissues of the coronary sinus. Astylet having a predetermined curve at the distal end and a handle atthe proximal end is removably located within the infusion lumen. Thepredetermined curve at one end of the stylet enables the cardioplegiacatheter to be inserted quickly and accurately within the coronary sinusthrough a very small incision made in the right atrium. After thecatheter is securerd in place, the stylet is withdrawn. The catheterremains in position for the duration of the operation in order toperiodically readminister the cardioplegia solution.

U.S. Pat. No. 5,004,455, to Greenwood, et. al., teaches a ballooncatheter which comprises a balloon catheter body, a balloon, a mainpassage and an auxiliary passage. The balloon is provided on theperiphery of the tip portion of the catheter body to inflate forblocking a bloodstream at a desired site inside blood vessels. Theauxiliary passage is provided for inflating the balloon. The mainpassage is provided behind the balloon, having an opening to eject adrug. The tip portion of the balloon catheter is inserted into one ofbranches of the blood vessel near targeted affected part. A fluid isinjected into the balloon so that the balloon blocks a bloodstream inthe branches. Therefore, a drug is ejected through the main passage ofthe balloon catheter into other branches.

U.S. Pat. No. 4,883,459, to Calderon, teaches the study of tumors in thebody of a patient in situ by a monitor, such as computer assistedtomography, X-ray or the like, while optimal flow paths through thetumor area are established. A catheter with a suction lumen and aninfusion lumen, with seals associated with each, is placed in thepatient's vein near the tumor. Flow is then sealed in the vein with theinfusion seal. A carrier medium dye is injected into the tumor atselected flow rates and differential pressures. Flow of the dye throughthe tumor is observed on the monitor to determine optimal retrogradeperfusion paths through the tumor for the selected flow rates anddifferential pressures. Once the optimal perfusion paths are noted, apreferential attack area in the tumor is located using a different, lessdense carrier dye and increased fluid back pressure in the infusionsystem. Once the attack area in the tumor is located, microspheres withactive ingredients, such as chemotherapy, can be selectively perfusedthrough one of the paths in the tumor to the attack site and forced intothe tumor, once at the attack site, using increased back pressure. Theprocess may be cyclically repeated using the same or different activeingredients. The procedure may be repeated through the tumor indifferent paths and attack points at desired active ingredient dosagesusing increased back pressures.

U.S. Pat. No. 4,867,742, to Calderon, teaches the study of tumors in thebody of a patient in situ by a monitor, such as computer assistedtomography, X-ray or the like, while optimal flow paths through thetumor area are established. A catheter with a suction lumen and aninfusion lumen, with seals associated with each, is placed in thepatient's vein near the tumor. Flow is then sealed in the vein with theinfusion seal. A carrier medium dye is injected into the tumor atselected flow rates and differential pressures. Flow of the dye throughthe tumor is observed on the monitor to determine optimal retrogradeperfusion paths through the tumor for the selected flow rates anddifferential pressures. Once the optimal perfusion paths are noted,microspheres with active ingredients, such as chemotherapy, can beselectively perfused through each of the paths in the tumor at desiredflow rates, pressures and active ingredient dosages. Alternatively,microspheres with different active ingredients can be selectivelyintroduced through the tumor in different paths at desired activeingredient dosages and established flow rates and pressures.

U.S. Pat. No. 4,820,261, to Schmoll, et. al., a device for the removalof active substances locally applied against solid tumors consists of acatheter (1) to be positioned distally to the tumor for the collectionof blood coming from the tumor, a pump (2) and a catheter (3) connectedthereto and returning the blood into the body. The device ischaracterized in that between the two catheters (1, 3) there is presentat least one container (4) capable of allowing blood to passtherethrough and containing immobilized antibodies against the appliedactive substance.

U.S. Pat. No. 4,714,460, to Calderon, teaches catheter feedback methodsand systems for optimizing the infusion of a drug, such as achemotherapeutic agent via retrograde perfusion through the venous sideof the vascular network to a selectively determined portion of a solidtumor. Monitoring and regulatory capability are provided for controllingthe outflow of the drug and thereby for controlling the dose rate, theduration of exposure of the drug, the leakage factor, and the level ofsystemic toxicity, all critical factors in the successful treatment ofsolid tumors. A feedback loop for practicing the method comprises twoconcentric balloon catheters capable of extensive maneuvering andselective placement within the venous drainage of the vascular system,creating a third in-vivo space for repeated perfusion of the selectedportion of a diseased organ as often as desired, providing maximumexposure of the chemotherapy to the tumor with minimum exposure to anyother portions of the patient's body.

It is well known that blood is primarily fed to a pelvic tumor by way ofthe iliac artery, and primarily withdrawn by way of the iliac vein.Prior art apparatuses and processes similar to the instant invention,have been for the most part taylored to tumors occurring in variousorgans, i.e., most particularly, the liver, which have well defined feedarteries and veins. Despite the plethora of such prior art apparatusesand processes, there has hitherto been no effective manner to apply themto localized tumors occurring in the pelvic cavity of a patientinflicted with, i.e., cancer. Thus there has been a long felt need foran apparatus and process for treating localized tumors occurring in thepelvic cavity of a patient inflicted with cancer.

SUMMARY OF THE INVENTION

It is the primary object of the instant invention to accomodate the longfelt need for an apparatus and process for treating localized tumorsoccurring in the pelvic cavity of a patient inflicted with cancer.

The instant invention in large part solves the problems of the prior andfulfills a long felt need by providing a novel apparatus and process.

The instant invention provides a novel catheter for use in the treatmentof tumors which occur in the pelvic cavity of a patient.

The instant invention provides a novel method of using a catheter foruse in the treatment of tumors which occur in the pelvic cavity of apatient.

The instant invention provides a novel catheter and a novel method ofits use in the treatment of tumors which occur in the pelvic cavity of apatient.

The instant invention provides a novel kit which includes a novelcatheter and a novel method of its use in the treatment of tumors whichoccur in the pelvic cavity of a patient inflicted with cancer.

Here are the more important features of the invention as broadlyoutlined, in order that the detailed description that follows may bebetter understood; and in order for the present contribution to the artmay be better appreciated. There are additional features of theinvention that will be described hereinafter and which form the subjectmatter of the appended claims. Those of ordinary skill in the art willappreciate that the conception upon which this disclosure is based mayreadily be utilized as a basis for the designing of other structures,methods and systems for carrying out the several purposes of the instantinvention. It is important, therefore, that the claims be regarded asincluding such equivalent constructions insofar as they do not departfrom the spirit and scope of the instant invention.

Further, the purpose of the instant abstract is to enable the U.S.Patent and Trademark office and the public generally, and especially thescientists, engineers and practitioners in the art who are not familiarwith patent or legal terms or phraseology, to determine quickly from acursory inspection of it, the technical disclosure of the patentapplication. The abstract is neither intended to define the invention ofthe instant patent application, which is measured by the claims, nor isit intended in any manner to be limiting as to the scope of the instantinvention.

In light of the foregoing, it is therefore an object of the instantinvention to provide a new and improved apparatus and process which hasall of the advantages of the prior art and none of its disadvantages.

It is another object of the instant invention to provide a new andimproved apparatus and process which may be easily and efficientlymanufactured and marketed.

It is another object of the instant invention to provide a new andimproved apparatus which is of a durable and reliable construction.

It is another object of the instant invention to provide a new andimproved apparatus which can be manufactured at correspondingly lowercost with regard to both labor and materials, and which accordingly canbe sold at a correspondingly lower cost, thus promoting commerce.

It is a further object of the instant invention to provide a new andimproved apparatus and method which provides at least some of theadvantages of the prior art schemes, while simultaneously eliminating atleast some of the disadvantages of them.

It is a further object of the instant invention to provide a new andimproved apparatus and process which is particularly designed foraccommodating the treatment of tumors occurring in the pelvic cavity ofa patient inflicted with cancer.

Other objects, features, and advantages of the instant invention, in itsdetails of construction and arrangement of parts, will be seen from theabove, from the following description of the preferred embodiment whenconsidered in light of the drawings and the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the basic apparatus of the invention as shown inrelationship the pelvic cavity of the body of a patient.

FIG. 2 depicts a diagrammatic of an apparatus assembly for carrying outthe process of the invention.

FIG. 3 depicts a partial cross-sectional side view of a firstalternative embodiment of a double balloon catheter as contemplated bythe invention.

FIG. 4 shows a cross-sectional end view of the shaft of the doubleballoon catheter of FIG. 3.

FIG. 5 shows a cross-sectional end view of the midsection of amodification of the double balloon catheter of FIG. 3.

FIG. 6 shows a partial cross-sectional side view of another design ofdouble balloon catheter useful in the process of the invention.

FIG. 7 shows a cross-sectional end view of the shaft of the doubleballoon catheter of FIG. 6.

FIG. 8 shows a cutaway cross-sectional side view of the interior of adouble balloon catheter encompassed by the invention.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1, shows the basic apparatus used to practice the process of theinstant invention in relationship to the pelvic cavity of a patient. Theinstant invention is primarily applicable to tumors located in thepelvic cavity which are fed by blood from the aorta and from which bloodis discharged to the vena cava. The invention is practiced by creating alocalized fluid circuit which isolates the tumor for maximum recycle ofa chemotherapeutic agent therethrough, while minimizing flow of theagent through the heathy tissues surrounding the tumor 3. The blood flowpath to the patient's heart via the iliac vein is isolated by a commoniliac catheter 9 and bilateral thigh tourniquets 8. Tumor 3 locatedwithin the thusly isolated circuit is thereafter infused withchemotherapeutic drugs via aortic occlusion catheter 4 and vena cavaocclusion catheter 3. The blood passing through the aorta and vena cavais infused with concentrations of a chemotherapeutic agent lethal to thecancer cells of the tumor 3 via aortic occlusion catheter 4 and venacava catheter 3. The thusly infused blood is passed via the common iliacvein to the common iliac vein catheter 9, typically a double ballooncatheter. The balloons of the double balloon catheter 9 are positionedcentral and peripheral of the common iliac vein. The balloons arecritically designed, sized and spaced such that after inflation, theycan accommodate the geometric constrains of the patient's common iliacvein, thus isolating substantially all of the outflow blood from thetumor 3. Substantially all of the contaminated blood is passed throughthe double balloon catheter to tubing 17 to a point exterior to the body2, to a pump 21. Typical of such a pump is a Bio Medicus BP-50 Bio-Pumphaving a priming volume of 48 ml, containing two rotator cones andproviding a maximum flow rate of 5 liters per minute. Pump 21 passes theblood through the extracorporeal circuit at relatively constant lowpressure. The purpose in doing so is to avoid raising or lowering thefluid pressure of the total circuit ranging from the blood vesselthrough the return to the body. The contaminated blood is thereafterpassed through tubing 41 into detoxification zone 43. Typical of such adetoxifiction zone is a hemoperfusion cartridge containing activatedcarbon. Suitable cartridge systems are obtainable from Clark Researchand Development, Inc., New Orleans, La. 70121 and from GambroDialysatoren KG, d-7450 Hechingen, Federal Republic of Germany AUT 224(sold under the trademark of ADSORBA®). The detoxified blood is passedthrough tube 44 and infused back into the body of the patient throughthe common iliac artery via catheter 69.

FIG. 2 shows the schematic relationship between the isolated circuitwithin the pelvic cavity, the iliac vein catheter 9, through whichtoxified blood is passed from the tumor and the common iliac arterycatheter 69 through which detoxified blood is infused back into theiliac artery. Double balloon catheter 9 typically comprises centralballoon 11 and peripheral balloon 12, each injuxtaposition tocylindrical fenestration zone 8. Zone 8 contains fenestrations 13sufficient in total area to allow the complete removal of the toxifiedblood flow from the tumor into the catheter 9. The hollow interior (mainlumen) of catheter 9 is of sufficient size to completely remove theblood from the blood vessel without elevating blood pressure. Catheter 9is provided with channel 15 that is used to inject fluid into theballoons 11 and 12 for inflation or to withdraw fluids for deflation.The venous flow is passed through catheter 9 into openly connected tube17. Tube 17 may be interrupted by a pressure monitor the same asassembly A, discussed below, that is later provided in theextracorporeal circuit. Tube 17 may alternatively be connected directlywith pump 21 or to Y-fitting 19, as shown. Also connected to Y-fitting19 is ancillary feed system B comprising tube 23, Y-fitting 25, andmultiple IV spikes 29 and 33 each connected to tubes 30 and 31respectively, and each is provided with a clamp, 27 and 28,respectively. These lines can be used for the introduction ofmedications as required.

Typically, pump 21 is a smooth rotator pump design and a particularlydesirable pump is a Bio Medicus BP-50 Bio-Pump having a priming volumeof 48 ml, containing two rotator cones and providing a maximum flow rateof 5 liters per minute. The contaminated blood is gently pushed betweenthe smooth rotators 37 in zones 35 and issued from the pump through port39 into tube 41. Tube 41 is connected to cartridge or canister 43containing a meshed sack of activated carbon particles coated with anacrylic resin containing heparin, see Clark, supra. The outflow fromcartridge 43 is fed to tube 45 and then to tube 47 that is connected topressure monitoring assembly A. Pressure monitoring assembly A comprisesa pressure monitor gauge 55 connected to fluid membrane vessel 53 thatcontains a thin membrane that separates the gauge 55 from the blood invessel 53 and responds to the fluid pressure of the blood in vessel 53.That response is read by the gauge. Vessel 53 is connected to tubing 57,that is connected to stopcock 52. Stopcock 52 is connected to flexibletubing 59 that in turn is connected to stopcock 51, the latter securedin fitting 49.

Blood from tubing 47 is passed to Y-connector 63 via tubing 61, then totubings 65 and 67. Tubings 65 and 67 are each connected to catheter 69and another catheter (connected to tube 65) not shown. These cathetersare provided for returning the purified blood to the subclavian veins.

FIG. 3 depicts a double balloon catheter design typically having up to a24 French (Fr) O.D. Zone 100 is provided with slotted fenestrations 104in the solid plastic tubing 102. The open end 118 terminates thecatheter. End 118 is tapered to the caliber of an angiographic guidewire that will, under fluoroscope control, allow the catheter to beadvanced from the femoral vein to the proper location in the inferiorvena cava without risk of injury to the interior of the vessels.Appropriate guide wires may be, for example, 0.035, 0.038, or 0.045 inchin diameter. During treatment, the catheter end hole is closed using astandard angiographic apparatus (tip-occluding wire), that consists of athin wire long enough to traverse the length of the catheter at the endof which is a stainless steel bead just large enough to obstruct thecatheter's end-hole when advanced into it (similar to a metal stopperthat closes the outlet from a sink when advanced).

Alteratively, the end hole can be made 7-12 Fr in diameter in order toaccommodate a return catheter. The return catheter can be used to returntreated blood to the systemic circulation. The return catheter isadvanced over a guide wire through the main lumen of the double ballooncatheter and through the end hole 118 into the right atrium or superiorvena cava. The return catheter can be made to gradually taper its O.D.by decreasing its wall thickness, leaving the I.D. constant, since thelocation of the tip of the return catheter is not critical. The lengthover which the catheter tapers is arbitrary. The taper is constructed sothat the tip of the catheter is its narrowest O.D. and the O.D.increases toward the femoral vein. As this return catheter is advancedthrough the lumen of the main catheter the tip easily passes through theend hole 118 of the double balloon catheter. The tapered end of thereturn catheter is advanced until it obstructs the end hole 118,preventing systemic blood from entering the double balloon catheter whenthe balloons are inflated but leaving an open lumen through the returncatheter to return blood beyond the isolated venous segment withoutmixing with contaminated blood.

The catheter tubing (body) can be made of a variety of plastic materialssuch as polypropylene, polyethylene, polyvinylchloride, ethylenevinylacetate copolymers, polytetrafiuoroethylene, polyurethane, and thelike. A favorable plastic combination for catheters containing a returnlumen are a homogeneous mixture of high density polyethylene and linearlow density polyethylene. That combination gives favorable stiffness atambient conditions and allows the use of especially thin wallthicknesses. When the surface of the catheter is made of a plastic thatis difficult to bond with a balloon, the plastic may be treated first byone or more of a number of well known methods that make bondingpossible. The methods include plasma treatment, ozone treatment, and thelike. Balloons 110 and 114 may be made from a plurality of elastomericmaterials such as latex rubber, polyurethanes, spandex typepolyurethanes, EPDM rubber, and the like. The balloons are typicallyadhesively bonded at sheath surfaces 108 and 112, respectively. A widevariety of adhesives may be employed. Polyacrylonitrile type adhesives,rubber latex adhesives and the like may be used to secure the balloon tothe sheath surfaces 108 and 112.

FIG. 4 depicts a cross section of a typical catheterdesign such as thatshown in FIG. 3. The interior of the catheter contains main lumen 120and 4 additional lumina 124 molded into the outer wall 122. Theadditional lumina can be used for the various functions described above.

FIG. 5 depicts a cross section of an alternate embodiment of thecatheter of the instant invention similar to that shown in FIG. 3 butcontaining only three lumina. The interior of the catheter contains mainlumen 130 and two supplementary lumina 131 molded into segment 133 ofwall 135. The supplementary lumina can be used for the various functionsdescribed above.

FIG. 6 depicts yet another alternate embodiement of the double ballooncatheter of the instant invention, which can have an outside diameter of24 French such as in the fenestration zone 140 and an inside diameter ofless than 22 Fr. Zone 140 is provided with slotted fenestrations 141 inthe plastic tubing 142.

FIG. 7 depicts a cross sectional view of still yet another embodiment ofthe catheter of the instant invention showing a main lumen 150 and 3supplemental lumina 151.

FIG. 8 provides a more detailed schematic cross sectional side view of atypical double balloon catheter 161. In this depiction, the cathetersidewall 163 is penetrated by a plurality of fenestrations 165. The mainlumen 169 contains at its periphery supplemental lumina 170, 171 and173. Supplemental lumen 170 can be used to accommodate a guidewire,supplemental lumen 171 can be used to accommodate a pressure monitor,and supplemental lumen 173 is used to supply fluid to the balloons 166and 167 through openings 175 and 177.

The bilateral thigh tourniquets 8 are critical for resticting the flowof blood in the pelvic cavity at a point at within the pelvic cavity,opposite the heart of said patient relative to said tumor.

Prior to the instant invention, no effective or practical method and/orapparatus existed for for the treatment of tumors which occurred in anextremity, such as the arm or leg of a patient. Thus, common to all ofthe double balloon catheter embodiments of the instant invention is thecritical "customized" sizing and spacing of the respective elementsthereof, in accomodation to the varied sizes and dimensions of: theparticular tumor to be treated, and the blood vessel which withdraws theblood therefrom.

The term "tumor," as used herein, also spelled TUMOUR, also calledNEOPLASM, a mass of abnormal tissue that arises without obvious causefrom preexisting body cells, has no purposeful function, and ischaracterized by a tendency to autonomous and unrestrained growth.Tumors are quite different from inflammatory or other swellings becausethe cells in tumors are abnormal in their appearance and othercharacteristics. Abnormal cells--the kind that generally make uptumors--differ from normal cells in having undergone one or more of thefollowing alterations: (1) hypertrophy, or an increase in the size ofindividual cells; this feature is occasionally encountered in tumors butoccurs commonly in other conditions; (2) hyperplasia, or an increase inthe number of cells within a given zone; in some instances it mayconstitute the only criterion of tumor formation; (3) anaplasia, or aregression of the physical characteristics of a cell toward a moreprimitive or undifferentiated type; this is an almost constant featureof malignant tumors, though it occurs in other instances both in healthand in disease.

The term "cancer," as used herein refers to any one of a group of morethan 100 related diseases characterized by the uncontrolledmultiplication of abnormal cells in the body. If this multiplication ofcells occurs within a vital organ or tissue, normal function will beimpaired or halted, with possible fatal results. Tumors, which primarilyoccur with the advent of cancer, are classified as malignant or benign;intermediary forms exist, however, and benign bone tumor may presenttherapeutic problems because of its location. Primary bone tumors arecharacterized by their origin in the skeletal tissue elements, forexample, bone tissue tumors (the malignant osteogenic sarcoma and thebenign osteoma), cartilage tumors (the malignant chondrosarcoma and thebenign chondroma), bone marrow tumors (the malignant myeloma and thebenign eosinophilic granuloma). Metastatic (secondary) tumors aremalignant by definition and are characterized by their site of originTypically, tumors occurring in an extemety occur in the form of, i.e., abone lesion. A bone leasion is a malignant growth of the bone caused bymetastatic spread from cancer in other organs. Primary bone cancer isfairly uncommon, but bone lesions from metastases are seen in more thanhalf of all cancer patients at the time of death. There are two types ofmetastatic bone lesion: osteoblastic, in which new bone is laid down ina disorganized fashion, and osteolytic, in which bone is destroyed,causing fractures and deep bone pain. Lung, breast, kidney, and prostatecancers are the primary tumors that most commonly cause bone lesions;lung cancer causes a typical punched-out lytic lesion while breast andprostate tumors more often produce osteoblastic metastases. Bone lesionscommonly occur in the vertebral column, ribs, and pelvis, as well as inthe long bones of the arms and legs.

The occurrence of papillomatous tumors of the renal pelvis has alreadybeen mentioned. Similar tumors in the lower urinary tract give rise topainless hematuria. Workers with the chemicals naphthyl amine andbenzidine have a high incidence of bladder tumors, often multiple andrecurrent. Blood in the urine is the most frequent symptom, but bladderirritation with difficulty in urination appears later. Removal whenpracticable or destruction by diathermy are normal treatments.

X-ray examination of any part of the urinary tract after introduction ofa radiopaque substance (often an organic iodine derivative) that castsan X-ray shadow. This contrast fluid, which passes quickly into theurine, may be taken orally or injected intravenously. It may also beinjected directly into the area being examined. Tumors, tuberculousabscesses, kidney stones, and obstruction by prostatic enlargement maybe detected by this method. Specific types of urography includepyelography (examination of the kidney and ureter) and cystography(examination of the bladder). Motion-picture "voiding cystograms"provide evidence of gross reflux of urine into the ureters and pelvis ofthe kidney during voiding. Imaging techniques are used to determine theanatomical site, configuration, and level of functioning of the kidneys,pelvis, and ureters. A plain X ray nearly always precedes any other moreelaborate investigation, so that the size, outline, and position of thetwo kidneys, as well as information about the presence or absence ofcalcium-containing renal stones or zones of calcification can beascertained. Excretion urography is one of the simplest methods ofdefining these aspects more precisely, though this radiological methodis giving way to noninvasive imaging methods such as ultrasonography andnuclear magnetic resonance (NMR). In excretion urography, the kidneysare observed in X rays after intravenous injection of a radiopaqueiodine-containing compound that is excreted largely by glomerularfiltration within one hour of the injection. A series of X-ray images(nephrograms) then indicates when the contrast substance first appearsand reveals the increasing radiographic density of the renal tissue. TheX rays also indicate the position, size, and presence of scarring ortumors in the organs and provide an approximate comparison of functionin the two kidneys. Finally the dye collects in the bladder, revealingany rupture or tumor in this organ.

Multiple myeloma, also called PLASMA CELL MYELOMA, or MYELOMATOSIS,common malignant tumor in the bone marrow, usually occurring in middleage and later. It is slightly more common in males and affects mostlythe flat bones typically in the pelvis. The disease occurs when Blymphocytes or their precursors multiply into clones of cancerous plasmacells that produce massive amounts of antibody proteins. This antibody,called myeloma protein (q.v.), has no infection-fighting capability anddisplaces most healthy antibody in the blood. It can collect in thetubules of the kidney and cause renal failure. Bone destruction alsofrees calcium into the circulation, which may be redeposited in abnormalplaces, such as the kidney. Symptoms and signs include pain, anemia,weakness, a tendency to hemorrhage, and kidney insufficiency.Pathological bone fractures occur, and neurological symptoms may followthe collapse of affected vertebrae. The disease is progressive, and mostpatients die within three years of diagnosis. In the presence ofmultiple lesions, only symptomatic treatment is possible; when only onelesion is present, surgery or irradiation may arrest or cure thedisease.

The term "detoxification," and its variants, as used herein, includes,but is not necessarily limited to: cascade membrane plasmapheresis,hemodialysis, hemoperfusion, membrane plasmapheresis, peritonealdialysis, single-needle dialysis, hemosoption, hemoperfusion, regularperitoneal dialysis, recirculating peritoneal dialysis, continuousambulatory peritoneal dialysis (CAPD), hemoultrafiltration,hemofiltration, blood centrifugation, and the like.

The invention is applicable to muscle tumors. Muscle tumors are abnormaltissue growth located in or originating from muscle tissue. Tumors mayeither arise in muscle tissue or spread to it. Three major tumor typesmay appear; they are known as leiomyomas, rhabdomyomas, andrhabdomyosarcomas.

The invention is also particularly useful in treating i.e.,osteoclastoma also called GIANT-CELL Tumor OF BONE, a bone tumor foundpredominantly in the knee region, but also occurring in the wrist, hand,foot, arm, and pelvis. The giant cells (large, often multinucleatedcells) found in these tumors resemble osteoclasts, for which the tumoris inappropriately named. Usually seen in young adults between the agesof 20 and 40, this relatively uncommon, painful tumor is consideredpotentially malignant. Most tumors are benign at the outset and areremoved by curettage (scraping). Unfortunately, about 50 percent of thetumors removed in this way recur, of which a small percentage spread toother parts of the body (metastasize). Until now, this has prompted somephysicians to recommend more aggressive treatment, such as completeexcision or amputation.

The term "means" and its variants!, as used herein, means: any and/orall equivalent structure which when manipulated, will render the claimedfunction.

The term "process" or "method" and its variants! as used herein, means:(1): a natural phenomenon marked by gradual changes that lead toward aparticular result (2): a natural continuing activity or function; or, aseries of actions or operations conducing to an end; or, especially: acontinuous operation or treatment especially in manufacture.

Although the invention has been described with reference to certainpreferred embodiments, it will be appreciated that many variations andmodifications may be made within the scope of the broad principles ofthe invention. Hence, it is intended that the preferred embodiments andall of such variations and modifications be included within the scopeand spirit of the invention, as defined by the following claims.

I claim:
 1. Apparatus for isolated perfusion of the pelvic cavity of apatient comprising:a first catheter designed, sized and dimensioned foroccluding the aorta of said patient; a second catheter designed, sizedand dimensioned for occluding the vena cava of said patient; a thirdcatheter designed, sized and dimensioned for occluding the common iliacvein of said patient; a fourth catheter designed, sized and dimensionedfor returning detoxified blood to the common iliac artery of saidpatient; a pump having a suction port and a discharge port; a firstconduit for providing fluid communication between said third catheterand said suction port; a detoxification device having an inlet and anoutlet; a second conduit for providing fluid communication between saiddischarge port and said inlet; a third conduit for providing fluidcommunication between said outlet and said fourth catheter; and,bilateral thigh tourniquets for restricting the flow of blood betweenthe legs and said pelvic cavity of said patient.
 2. The apparatus ofclaim 1, wherein said third catheter further comprises structure forpercutaneous insertion into said common iliac vein, including (a) aplastic tube having a cranial end and a caudal end, said plastic tubedefining a main lumen for outflowing blood, two balloons, fixedly spacedapart about said plastic tube and bonded thereto for inflationthereabout, one being contiguous to said cranial end;wherein saidballoons are sized and spaced on said plastic tube sufficient, that wheninflated, they have sufficient size and spacing therebetween tosubstantially block the flow of blood in said common iliac vein and tosubstantially isolate outflow from said tumor to other portions of saidcommon iliac vein; fenestration in said plastic tube between saidballoons to said main lumen; second and third lumina within said plastictube;said second lumen connecting to one of said balloons; and, saidthird lumen connecting to the other of said balloons for effectinginflation or deflation of said balloons; said cranial end of saidplastic tube being closed to substantially all inflow of blood; and, areturn catheter for returning blood removed through said main lumen tothe patient.
 3. The apparatus of claim 2 wherein said plastic tube has afourth lumen sized to accommodate an angiographic guide wire.
 4. Theapparatus of claim 2 wherein said second and third lumina connect andare common to the interiors of said balloons.
 5. The apparatus of claim2 wherein said second and third lumina lie within the wall of saidplastic tube.
 6. A kit comprising:a first catheter designed, sized anddimensioned for occluding the aorta of said patient; a second catheterdesigned, sized and dimensioned for occluding the vena cava of saidpatient; a third catheter designed, sized and dimensioned for occludingthe common iliac vein of said patient; wherein said third catheterfurther comprises structure for percutaneous insertion into said commoniliac vein, including (a) a plastic tube having a cranial end and acaudal end, said plastic tube defining a main lumen for outflowingblood, two balloons, fixedly spaced apart about said plastic tube andbonded thereto for inflation thereabout, one being contiguous to saidcranial end; wherein said balloons are sized and spaced on said plastictube sufficient, that when inflated, they have sufficient size andspacing therebetween to substantially block the flow of blood in saidcommon iliac vein and to substantially isolate outflow from said tumorto other portions of said common iliac vein; fenestration in saidplastic tube between said balloons to said main lumen; second and thirdlumina within said plastic tube; said second lumen connecting to one ofsaid balloons; and, said third lumen connecting to the other of saidballoons for effecting inflation or deflation of said balloons; saidcranial end of said plastic tube being closed to substantially allinflow of blood; and, a return catheter for returning blood removedthrough said main lumen to the patient; a fourth catheter designed,sized and dimensioned for returning detoxified blood to the common iliacartery of said patient; a pump having a suction port and a dischargeport; a first conduit for providing fluid communication between saidthird catheter and said suction port; a detoxification device having aninlet and an outlet; a second conduit for providing fluid communicationbetween said discharge port and said inlet; a third conduit forproviding fluid communication between said outlet and said fourthcatheter; and, bilateral thigh tourniquets for restricting the flow ofblood between the legs and said pelvic cavity of said patient.
 7. Thekit of claim 6 wherein the detoxification device includes a deviceselected from the group consisting of devices designed to providehemoperfusion, hemodialysis, hemofiltration and hemoabsorption.
 8. Thekit of claim 6 wherein said second catheter is designed to fit withinsaid plastic tube and said cranial end tapers are designed to fitthereabout such that the treated blood is returned past the cranialballoon and said kit includes arterial injection means for introducingsaid treating agent into a common iliac vein leading to said tumor. 9.The kit of claim 6 wherein said treating agent is an anti-cancer agent.10. The kit of claim 6 further including an angiographic guide wire,wherein said cranial end is tapered to a diameter of an angiographicguide wire.
 11. A method for isolated pelvic perfusion comprising thesteps of:providing a kit which includes a first catheter designed, sizedand dimensioned for occluding the aorta of said patient; a secondcatheter designed, sized and dimensioned for occluding the vena cava ofsaid patient; a third catheter designed, sized and dimensioned foroccluding the common iliac vein of said patient; a fourth catheterdesigned, sized and dimensioned for returning detoxified blood to thecommon iliac artery of said patient; a pump having a suction port and adischarge port; a first conduit for providing fluid communicationbetween said third catheter and said suction port; a detoxificationdevice having an inlet and an outlet; a second conduit for providingfluid communication between said discharge port and said inlet; a thirdconduit for providing fluid communication between said outlet and saidfourth catheter; and, bilateral thigh tourniquets for restricting theflow of blood between the legs and said pelvic cavity of said patient;occluding said aorta with said first catheter; occluding said vena cavawith said second catheter; occluding said common iliac vein with saidthird catheter; occluding said common iliac artery with said fourthcatheter; restricting said flow of blood with said bilateral thightourniquets; perfusing chemotherapeutic agents into the pelvic cavitythrough said first and second catheters; withdrawing toxified blood fromsaid pelvic cavity through said third catheter; detoxifying saidtoxified blood with said detoxification device to provide detoxifiedblood; and, reinfusing said detoxified blood through said fourthcatheter.
 12. Apparatus for isolated perfusion of the pelvic cavity of apatient comprising:a first catheter designed, sized and dimensioned foroccluding the aorta of said patient; a second catheter designed, sizedand dimensioned for occluding the vena cava of said patient; a thirdcatheter designed, sized and dimensioned for occluding the common iliacvein of said patient; a fourth catheter designed, sized and dimensionedfor returning detoxified blood to the common iliac artery of saidpatient; a pump having a suction port and a discharge port; a firstconduit for providing fluid communication between said third catheterand said suction port; a detoxification device having an inlet and anoutlet; a second conduit for providing fluid communication between saiddischarge port and said inlet; a third conduit for providing fluidcommunication between said outlet and said fourth catheter; bilateralthigh tourniquets for restricting the flow of blood between the legs andsaid pelvic cavity of said patient; said third catheter furthercomprises structure for percutaneous insertion into said common iliacvein, including (a) a plastic tube having a cranial end and a caudalend, said plastic tube defining a main lumen for outflowing blood, twoballoons, fixedly spaced apart about said plastic tube and bondedthereto for inflation thereabout, one being contiguous to said cranialend; wherein said balloons are sized and spaced on said plastic tubesufficient, that when inflated, they have sufficient size and spacingtherebetween to substantially block the flow of blood in said commoniliac vein and to substantially isolate outflow from said tumor to otherportions of said common iliac vein; fenestration in said plastic tubebetween said balloons to said main lumen;second and third lumina withinsaid plastic tube; said second lumen connecting to one of said balloons;and, said third lumen connecting to the other of said balloons foreffecting inflation or deflation of said balloons; said cranial end ofsaid plastic tube being closed to substantially all inflow of blood; areturn catheter for returning blood removed through said main lumen tothe patient; and said cranial end is tapered to a diameter of anangiographic guide wire.